Country: United States
Language: English
Source: NLM (National Library of Medicine)
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)
Synergy Wound Technology, Inc
TOPICAL
OTC DRUG
Topical Antiseptic Antimicrobial skin cleanser helps reduce bacteria that potentially cause infection • For general skin and wound cleaning.
OTC monograph not final
BIOFILM BLAST MD- HYDROGEN PEROXIDE SPRAY SYNERGY WOUND TECHNOLOGY, INC _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- BIOFILM BLAST MD _DRUG FACTS_ _ACTIVE INGREDIENTS_ Hydrogen Peroxide 1 % (v/v) _PURPOSE_ Topical Antiseptic _USES:_ Antimicrobial skin cleanser helps reduce bacteria that potentially cause infection • For general skin and wound cleaning. _WARNINGS:_ FOR EXTERNAL USE ONLY. Do not use in eyes. Do not ingest. Do not use if allergic to ingredients. Discontinue use if irritation, redness or pain develops. If condition persists, consult a doctor. KEEP OUT OF REACH OF CHILDREN; for children 2 and under consult a physician before use. _DIRECTIONS FOR USE:_ Clean wound prior to use. Shake well then apply spray evenly over skin or wound area. Repeat spray application to gauze pad then lightly "fluff" gauze and pack into open wounds as appropriate. Reapply 1 to 3 times a day, or as directed by a physician. Stop use if condition worsens. _OTHER INFORMATION:_ Store between 20-25°C (68-77°F). Avoid direct sunlight. _INACTIVE INGREDIENTS:_ TM Purified water, silver hydrosol (proprietary) _QUESTIONS?_ info@biofilmblastmd.com _www.biofilmblastmd.com_ • SKIN AND WOUND CLEANSER • HELPS PREVENT INFECTION Distributed by InteliWound. San Diego, CA 92131 PACKAGING BIOFILM BLAST MD hydrogen peroxide spray PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:83279-401 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 1 mL in 100 mL Synergy Wound Technology, Inc INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) SILVER (UNII: 3M4G523W1G) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:83279- 401-10 28 mL in 1 BOTTLE, SP Read the complete document